Browse Device Recalls
11 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 11 FDA medical device recall enforcement actions. Each entry includes the device description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.
Medical Device Recalls
Browse 11 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Feb 3, 2020 | Dexcom G5 Continuous Glucose Monitoring System The Dexcom G4 PLATINUM Cont... | The company identified potential interference from hydroxyurea. Patient use of the anti-neoplasti... | Class II | Dexcom Inc |
| Feb 3, 2020 | Dexcom G4 PLATINUM Continuous Glucose Monitoring System The Dexcom G4 PLAT... | The company identified potential interference from hydroxyurea. Patient use of the anti-neoplasti... | Class II | Dexcom Inc |
| Feb 3, 2020 | Dexcom G6 Continuous Glucose Monitoring System The Dexcom G4 PLATINUM Cont... | The company identified potential interference from hydroxyurea. Patient use of the anti-neoplasti... | Class II | Dexcom Inc |
| Nov 19, 2019 | Brand Name: Dexcom G6 CGM App for iOS Software Number: SW11677 Software Ver... | It was reported that the user's low alarm feature on the iOS application were not properly alert... | Class II | Dexcom Inc |
| Jul 12, 2019 | Dexcom Receiver, REF: MT22719, (Black, Pin, Blue), Rx Only, containing softw... | It has been reported that use of the mobile receiver with software version SW10617 rev 4.0.1.048 ... | Class II | Dexcom Inc |
| Feb 23, 2016 | Dexcom G4 PLATINUM Receiver with Share Receiver Part Number: MT22495 Receive... | Customers may not receive an intended audible alarm or alert if relying on hearing the alarm or a... | Class I | Dexcom Inc |
| Feb 23, 2016 | Dexcom G4 PLATINUM (Pediatric) Receiver with Share Receiver Part Number: MT2... | Customers may not receive an intended audible alarm or alert if relying on hearing the alarm or a... | Class I | Dexcom Inc |
| Feb 23, 2016 | Dexcom G5 Mobile Receiver Receiver Part Number: MT22719 Receiver (mg/dL), Bl... | Customers may not receive an intended audible alarm or alert if relying on hearing the alarm or a... | Class I | Dexcom Inc |
| Feb 23, 2016 | Dexcom G4 PLATINUM Receiver Receiver Part Number: MT20649 Receiver (mg/dL), ... | Customers may not receive an intended audible alarm or alert if relying on hearing the alarm or a... | Class I | Dexcom Inc |
| Feb 23, 2016 | Dexcom G4 PLATINUM (Pediatric) Receiver Receiver Part Number: MT22430 Receiv... | Customers may not receive an intended audible alarm or alert if relying on hearing the alarm or a... | Class I | Dexcom Inc |
| Feb 23, 2016 | Dexcom G4 PLATINUM (Professional) Receiver Receiver Part Number: MT20649 Rec... | Customers may not receive an intended audible alarm or alert if relying on hearing the alarm or a... | Class I | Dexcom Inc |
Frequently Asked Questions
When a device safety issue is identified, the manufacturer or FDA initiates a recall. The FDA publishes an enforcement report detailing the device, the reason for the recall, and distribution. Healthcare facilities and providers are notified to check their inventory and take corrective action.
All types — from simple devices like blood glucose test strips and surgical gloves to complex devices like pacemakers, defibrillators, insulin pumps, hip implants, and ventilators. Software-driven devices are increasingly common in recalls due to bugs and cybersecurity vulnerabilities.
Use the search and filter tools on this page. Each recall entry includes the device description, model numbers, and distribution details so you can determine if your device is affected. Contact your healthcare provider if you find a match.